BK Medical ApS Ultrasound System Scanner bk2300 - Model #: bk3500 with software releases 1.2.0, 1.2.1 and 1.2.2. The system is intended for diagnostic ultrasound imaging or fluid flow analysis of the human body, data processing and guidance of puncture and biopsy. The system performs simple geometric measurements and calculations in the following areas: Emergency Medicine, Anesthesia, MSK, Vascular, Cardiology, OB/GYN
This recall has been terminated (originally issued June 28, 2016).
- Recall Initiated
- June 28, 2016
- Terminated
- August 29, 2016
- Recall Number
- Z-2325-2016
- Quantity
- 6
- Official Source
- View on FDA website ↗
Reason for Recall
In the system (bk3500) software generic volume measurement (HxWxLxl) function the user may be unaware of the calculation factor (1) and assume the generic volume calculation factor is similar to that of the other (prostate, adenoma, testis, kidney, and bladder) volume calculation factors provided in the software.
Distribution
Worldwide Distribution - US to TX, FL, and MA. Internationally to Australia
Lot / Code Info
Serial Numbers: 5007750, 5008004, 5007734,5007742, 5007596, and50074277
Root Cause
Software design
Action Taken
BK Medical sent an Important Corrective Action Notification letter dated June 27, 2016, to all affected customers. The letter explains the issue and asks customers to discontinue the use of the generic volume measurement and contact BK medical ApS Service for assistance. Customers with questions were instructed to call 800-645-4442.